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Site Management

MENE Research

Mene SMO resources Clinical Research Coordinators to coordinate with the PI, support, facilitate and coordinate the daily clinical trial activities and play a critical role in the conduct of the study.

Mene SMO able to resourcing The Clinical Research Coordinators (CRC). In order to meet requirements of part-time, full time by sponsor All Mene SMO CRCs are specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.

By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study according to Delegation Sheet filled prior to start up. The clinical research coordinator reports primarily to the Principal Investigator with associated responsibilities to the department head, division administrator or program administrator.

Coordinates with Principal Investigator, department, and central administration to help ensure that clinical research and related activities are performed in accordance with Local regulations and University and sponsoring agency policies and procedures.

Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.

Assists Principal Investigator to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with local regulations and University and sponsoring agency policies and procedures.

Cooperates with University compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by Authorities and sponsors.

Collaborates with PI and institution to respond to any audit findings and implement approved recommendations.

Cooperates with University and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.

Conduct of Research

Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, local required docs, etc.).

Works with the PI to develop and implement recruitment strategies in accordance with CEC requirements and approvals.

Conducts or participates in the informed consent process including interactions with the CEC and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.

Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.

Registers participants to the appropriate coordinating center (if multi-site study).

Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.

Coordinates participant tests and procedures.

Collects data as required by the protocol. Assures timely completion of Case Report Forms.

Maintains study timelines.

Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/ or Investigational Drug/Device Accountability.
Retains all study records in accordance with sponsor requirements and procedures.

Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.

Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management.

Arranges secure storage of study documents that will be maintained according to local guidelines

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